NCT06696183

Brief Summary

Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
47mo left

Started Apr 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Apr 2025Apr 2030

First Submitted

Initial submission to the registry

November 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

November 7, 2024

Last Update Submit

May 27, 2025

Conditions

AML - Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Ratio of dose delivered/dose planned

    12 months

Study Arms (4)

Cohort 1

EXPERIMENTAL

GILT d1-d28 VEN d1-d7 AZA d1-d7

Drug: Gilteritinib (GILT)Drug: Venetoclax (VEN)Drug: Azacitidine (AZA)

Cohort 2

EXPERIMENTAL

GILT d8-d28 VEN d1-d7 AZA d1-d7

Drug: Gilteritinib (GILT)Drug: Venetoclax (VEN)Drug: Azacitidine (AZA)

Cohort 3

EXPERIMENTAL

GILT d1-d28 VEN d1-d14 AZA d1-d7

Drug: Gilteritinib (GILT)Drug: Venetoclax (VEN)Drug: Azacitidine (AZA)

Cohort 4

EXPERIMENTAL

GILT d8-d28 VEN d1-d14 AZA d1-d7

Drug: Gilteritinib (GILT)Drug: Venetoclax (VEN)Drug: Azacitidine (AZA)

Interventions

Gilteritinib (GILT)DRUG

80 mg

Cohort 1Cohort 2Cohort 3Cohort 4
Venetoclax (VEN)DRUG

400 mg

Cohort 1Cohort 2Cohort 3Cohort 4
Azacitidine (AZA)DRUG

75 mg/m²

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL
  • FLT3 mutation at initial diagnosis
  • Ineligibility of standard induction chemotherapy
  • Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)

You may not qualify if:

  • R/R AML
  • Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
  • Previous treatment with Gilteritinib
  • Known active CNS involvement
  • QTcF \>450 ms or long QT Syndrome at screening
  • Treatment with concomitant strong CYP3A inducers or St. John's wort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

gilteritinibvenetoclaxAzacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Central Study Contacts

Prof. Dr. Christoph Röllig, MD, MSc

CONTACT

+49 351 458 4190sequence@ukdd.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 20, 2024

Study Start

April 25, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

DE(1)